2016 ACR/EULAR Classification Criteria for Primary Sjögren’s Syndrome

RheumatologyAutoimmune diseaseClassification criteriaBeta toolThis tool is in beta. It has undergone internal validation but still requires additional testing. Always confirm the data entered and the results obtained before clinical use. It should not be used as the sole basis for clinical decisions.

Labial salivary gland biopsy positivePositive only when focal lymphocytic sialadenitis with focus score >=1 focus per 4 mm² is present.

YesNo

Anti-SSA/Ro positiveUse the published anti-SSA/Ro item only; isolated anti-SSB/La, ANA, or RF positivity does not substitute.

YesNo

Ocular staining positivePositive only when ocular staining score is >=5 or van Bijsterveld score is >=4 in at least 1 eye.

YesNo

Schirmer test positivePositive only when Schirmer test is <=5 mm per 5 minutes in at least 1 eye.

YesNo

Unstimulated whole saliva flow positivePositive only when unstimulated whole saliva flow rate is <=0.1 mL per minute.

YesNo

Any exclusion condition presentSelect Yes if there is head and neck radiation history, active hepatitis C confirmed by PCR, advanced HIV infection, sarcoidosis, amyloidosis, graft-versus-host disease, or IgG4-related disease.

YesNo

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Clinical noticeEducational classification support only. Use the 2016 ACR/EULAR criteria in the appropriate clinical context and not as a stand-alone diagnostic rule.

Context and use

Total score = 3 x positive labial biopsy + 3 x anti-SSA/Ro positive + positive ocular staining + positive Schirmer + positive unstimulated whole saliva flow

Classify at >=4 points only when no published exclusion condition is present.

If any exclusion condition is present, the criteria are not applicable and the weighted score should not be interpreted.